What is FDA’s stance on CBD in cosmetics?

Is CBD legal in cosmetics?

GanedenBC30, a branded probiotic used in multiple food and beverage categories, was approved in Australian and New Zealand for a range of digestive-health claims supported by a wealth of scientific evidence.

The FSANZ (Food Standards Australia New Zealand) Food Standards code sets out the requirements for making a general-level health claim. Companies that want to make a claim can go through a systematic review of evidence of a causal food-health relationship. With 25 published papers supporting the efficacy of GanedenBC30’s benefits for digestive health, the ingredient’s manufacturers, Kerry (Beloit, WI), was able to conduct a comprehensive review in line with the ANZ Food Standards code.

The claims include “aids digestive health”, “supports digestive health”, and “boosts digestive health”. In addition to the volume of evidence supporting its benefits, as a spore-forming probiotic, GanedenBC30 remains viable through shelf life and the low pH of stomach acid, as well as processing conditions like heat, shear, and HPP pasteurization.

“As in the rest of the world, demand for probiotic products in Australia has soared in recent years,” said John Quilter, vice president and general manager for GanedenBC30, in a press release. “The door is now open for manufacturers to use messaging highlighting the many benefits of GanedenBC30. In addition to being backed by a wealth of scientific evidence, it’s a highly resilient probiotic strain, opening up opportunities for innovation in a range of food and beverage categories.”

“Consumers are increasingly skeptical and rightly asking questions about the effectiveness of functional ingredients such as probiotics,” Quilter said. “The best way to respond is by clearly communicating benefits and the research supporting them. Scientific substantiation helps manufacturers and consumers alike understand the value of ingredients and choose products that can really support health.”

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GanedenBC30, a branded probiotic used in multiple food and beverage categories, was approved in Australian and New Zealand for a range of digestive-health claims supported by a wealth of scientific evidence. 

Australia, New Zealand publish digestive claims for GanedenBC30

The American Herbal Products Association (AHPA; Washington, D.C.) sent a 

 to the U.S. Department of Agriculture's (USDA's) Agricultural Marketing Service (AMS) to support adding pullulan to the National List at 7 CFR § 205.605 as a nonagricultural (nonorganic) ingredient that can be used only in tablets and capsules for dietary supplements labeled, “Made with organic (specified ingredients or food group(s)).” AHPA membership includes numerous companies that grow herbal crops or market herbal products certified as organic under USDA’s National Organic Program (NOP), including capsuled dietary supplements that include pullulan as an ingredient.

On June 8, 2020, USDA’s AMS issued a proposed rule to amend the National List of Allowed and Prohibited Substances within USDA’s organic regulations by adding several substances to implement recommendations submitted to the Secretary of Agriculture by the National Organic Standards Board (NOSB), which included the proposal to add pullulan. AHPA explains in its comments that pullulan has a history of use in encapsulated supplement products classified as organic by the NOP because pullulan was previously classified as agricultural. This was until December of 2016, when pullulan was classified as a nonagricultural substance. 

Pullulan’s inclusion to the National List would maintain the status quo by allowing dietary supplements in tablets and capsules that include pullulan to continue to be labeled, “Made with organic (specified ingredients or food group(s)).” Pullulan is currently a key ingredient in non-animal-sourced capsules, as a vegetarian alternative to gelatin.

“The addition of pullulan to the National List at 7 CFR § 205.605 will ensure that the option of vegetarian herbal supplement capsules continues to be available, thus supporting both the farmers who grow organic herbs and the consumers who choose to include supplements in this form in their personal health care choices,” said AHPA in its letter.

AHPA also expressed support for comments submitted by the Organic Trade Association (OTA), which go into greater detail on the issue of adding pullulan to the National List.

AHPA supports the addition of pullulan to the National List at 7 CFR § 205.605 as a nonagricultural (nonorganic) ingredient that can be used only in tablets and capsules for dietary supplements labeled, “Made with organic (specified ingredients or food group(s)).”

AHPA supports USDA’s proposal to allow pullulan in products labeled organic 

 conducted by Pharmavite LLC (West Hills, CA) shows that older adults living below the poverty line have inadequate intakes of calcium and vitamin D, putting them at greater risk of osteoporosis. Researchers performed a cross-sectional analysis of United States population using National Health and Nutrition Examination Survey (NHANES) data from 2007–2010 and 2013–2014 for older US adults (n = 3,901 participants, 50 years old and older).

According to the study, based on current U.S. population estimates, 14 million Americans age 50 and older are expected to have suffered from probable osteoporosis in 2019, representing about 10% of the total Americans in this age group. Within this group, women are more likely to be affected (16.2%) compared to men (4.6%). Looking at these figures from a nutrient intake perspective, the researchers estimate that 60% of the cohort have inadequate calcium intakes (72.4% of females; 51.4% of males) and 36.7% (24.1% of females; 39.7% of males) of this cohort have inadequate vitamin D intake. Of Americans over the age of 50 and older, it’s estimated that only 30% supplement with calcium and vitamin D.

Among Americans ages 50 and older, an estimate 23% belong to households with an annual income below $20,000. Researchers determined that 68% (74.3% of females; 58.9% of males) of this income bracket have inadequate calcium intake level, and 43% (39.4% of females; 46.7% of males) have inadequate vitamin D intake. Household income is also strongly associated with relative risk of osteoporosis. Adults 50 years of age or older belonging to a household with a household income less than $20,000 have a 60% relative risk of osteoporosis, compared to high income brackets. When considering the combined effect of household income and nutrient intake, researchers determined that the relative risk of osteoporosis was greater by 45% for those with inadequate intakes of calcium, by 41.1% for those with inadequate intakes of vitamin D.

When analyzing this data by ethnicity, the effect of poverty levels on risk of osteoporosis had the greatest impact on Mexican Americans, specifically females, and non-Hispanic whites of both genders. In addition, non-Hispanic black men with lower incomes are twice as likely to develop osteoporosis compared to higher income counterparts, despite a lower risk of osteoporosis among non-Hispanic black people overall. While food insecurity does play a significant role on inadequate intakes of calcium and vitamin D, it does not appear to play a large role in relative risk of osteoporosis unless ethnicity is taken into consideration. Non-Hispanic whites reporting food insecurity have a 68.1% greater relative risk of osteoporosis compared to food secure counterparts, and food-insecure Mexican Americans have a 26% greater relative risk of osteoporosis.

“This study continues to demonstrate how prevalent nutrient deficiency is among the U.S. population, and even more so, among lower income individuals and those with food insecurities,” said Susan Hazels Mitmesser, PhD, vice president of science and technology at Pharmavite, in a press release. “Improving the consumption of nutrient-rich and fortified foods among individuals that live in poverty can help to decrease their chances of developing osteoporosis. Additionally, dietary supplements can play a critical role in helping any underserved population meet their nutrition needs —including making supplements readily available through programs like SNAP, for example. Our research demonstrates that participants with SNAP benefits and more access to food, have fewer nutrient inadequacies which helps them meet their nutrition needs.”

Marshall K et al. “Inadequate calcium and vitamin D intake and osteoporosis risk in older Americans living in poverty with food insecurities.” 

, Published online ahead of print on July 8, 2020

A recent study conducted by Pharmavite LLC shows that older adults living below the poverty line have inadequate intakes of calcium and vitamin D, putting them at greater risk of osteoporosis. 

Poverty associated with inadequate intakes of calcium and vitamin D, says recent study

Oil derived from ratites, a family of flightless birds that includes emus and ostriches, is used extensively in the cosmetic and pharmaceutical industries because of the oil’s reputable moisturizing, penetrating, and therapeutic qualities for humans and animals.

Fun fact! Oil derived from ratites, a family of flightless birds that includes emus and ostriches, is used extensively in the cosmetics and pharmaceutical industries because of the oil’s reputable moisturizing, penetrating, and therapeutic qualities for humans and animals. 

Ratite oil from ostriches and emus used in cosmetics and drugs

Stratum Nutrition, a business of ESM Technologies (Carthage, MO), entered into a value-added distribution agreement for NatAxtin brand astaxanthin, manufactured by Atacama Bio Natural Products (Iquique, Chile).

"We are really excited to launch NatAxtin branded astaxanthin in North America and could not ask for a better partner than Stratum Nutrition to accomplish this,” said Jose Luis Arenas, founder and CEO of Atacama Bio, in a press release.

NatAxtin is a competitively priced astaxanthin that combines the benefits of an optimal microbial source and ideal production conditions, resulting in an ingredient that meets or exceeds the high standards demanded by conscientious dietary supplement manufacturers.

"Stratum is well on a path to leadership in supplying all-natural and proven-effective dietary solutions,” said Micah Osborne, President of Stratum Nutrition, in a press release. “Bringing NatAxtin brand astaxanthin into Stratum's highly selective portfolio fully complements the range of unique plant, animal, and probiotic ingredients we produce and distribute."

Stratum Nutrition has entered into a distribution agreement with Atacama Bio Natural Products for its NatAxtin branded astaxanthin.

Stratum Nutrition to distribute NatAxtin branded astaxanthin in North America

Nutrition industry professionals are taking stock of how they can help their communities during the COVID-19 pandemic. Many other industries have found ways to assist others in this difficult time. Makers and sellers of dietary supplements have long had a mission, through their products, to help consumers fill nutrient gaps and stay well. It’s a role that remains critical at a time when staying healthy is of utmost concern.

We have seen industry companies find numerous ways to support their communities in recent months. Some have produced and 

 to those on the front lines. Still others have donated significant funds to help their communities who are in need of a wide range of relief, such as the nonprofit Dr. Majeed Foundation 

. These are just a few examples of how supplement companies have found ways to help.

Recently, the Pharmavite corporation announced a new initiative called 

, which specifically focuses on helping nurse practitioners better care for themselves as they battle on the pandemic front line. In early March, even before nationwide lockdowns started, the company surveyed 350 nurse practitioners in the U.S. to determine how these workers were managing their own wellbeing.

“The original intent of the survey was to better understand what nurse practitioners prioritize in their health routines and what factors dictate their behaviors,” explains Alan McNamara, Pharmavite’s divisional vice president of corporate communications. “Once we conducted our survey, COVID-19 quickly came to the forefront and it was apparent we needed to lend our support beyond sharing the insights we gathered.”

The Caring by Nature program has evolved into a program that offers numerous channels to help nurse practitioners bolster their health and wellness during the pandemic. These include educational resources and interactive options such as virtual yoga classes led by professional instructors as well as free care packages containing products from Pharmavite’s Nature Made brand. These are “products designed to help support relaxation and stress-reduction,” McNamara says. Nurse practitioners can register via the following link to participate in the Caring by Nature program for free: 

http://www.jaanpresourcecenter.com/specialty/pharmavitenatmade.html.html.html

Pharmavite also harnessed the partnership of the American Association of Nurse Practitioners to help drive the initiative’s exposure and extend its reach. “Similarly, we have partnered with select nurse practitioner social influencers to speak to the survey results as well as the yoga classes and care package offerings,” McNamara says.

Nurse practitioners are a group that needs this kind of support, especially in the high-stress and hazardous environment they now face due to COVID-19. One finding from Pharmavite’s survey is that nurse practitioners generally prioritize their health and wellness behind the needs of others.

“Our survey was fielded in early March at the start of the global pandemic. It’s no secret that healthcare professionals like nurse practitioners have always worked tirelessly for the greater good of their patients, but the results were eye-opening,” McNamara says. “Our survey found that nearly half (44%) of nurse practitioners reported being ‘too tired’ as the top reason preventing them from taking better care of themselves and their health.” In fact, 54% of respondents said that work commitments prevent them from taking better care of their health.

McNamara says this spurred the company to find a tangible way to support this group of healthcare workers. “Our key takeaway that nurse practitioners generally put the care and wellbeing of others above their own needs really struck a chord given the toll the pandemic was taking on both frontline healthcare workers and the healthcare system itself,” he says. “Rather than just raise awareness around this issue, we wanted to do something that might help them through this difficult time.”

One finding of the survey was that even as nurse practitioners push other personal health priorities to the side, one thing they do prioritize is the use of dietary supplements. The survey found 77% of respondents reporting routinely taking a vitamin and/or a dietary supplement daily, primarily citing immune system support and filling nutrient gaps as the main reasons. Says McNamara, “[D]espite their busy schedules, the majority of nurse practitioners reported that regularly takin vitamins or supplements is the last healthy habit to fall by the wayside, in comparison to other habits such as eating healthy or exercising. When you layer in the impact COVID-19 has had on our healthcare system, these findings are likely amplified.”

McNamara says Pharmavite is also “definitely open to expanding the reach of this program to other healthcare workers. Any future iterations of this program would be tailored to providing resources and supporting the needs of that specific group of healthcare workers.”

He adds: “Pharmavite has been a longtime supporter of the healthcare professional community by investing in education on nutrients for this vital group of individuals who are trusted sources of information for their patients.” By spreading the word and encouraging the use of dietary supplements, companies like Pharmavite are demonstrating to healthcare providers as well as the people those providers influence about how supplements can play a beneficial role in this difficult time. While supplements cannot in any way prevent, treat, or cure COVID-19, they can help consumers take care of their themselves at a time when everyone is worried about their health.

Pharmavite's Caring by Nature program has evolved into a program that offers numerous channels to help nurse practitioners bolster their health and wellness during the pandemic. 

Pharmavite’s new Caring by Nature initiative supports nurse practitioners’ health as they deal with COVID-19 work stress

As hard seltzers’ popularity expanded across the globe through 2020, new competitors and flavor varieties have emerged. To help companies differentiate their product lines through flavor innovation, Gold Coast Ingredients (Santa Fe Springs, CA) offers natural, TTB-approved flavors for hard seltzers:

Each flavor can be made non-GMO, certified organic, and allergen-free to meet product requirements.

To help companies differentiate their product lines through flavor innovation, Gold Coast Ingredients now offers new TTB-approved flavors for hard seltzers. 

Gold Coast introduces new flavors for hard seltzer products

Sabinsa (East Windsor, NJ) launched a new formula, called LivLonga, to support healthy liver function. LivLonga is a blend of three of Sabinsa’s ingredients: 250 mg of Curcumin C3 Complex Turmeric (

) extract, 50 mg of Livinol Kokum fruit (

) extract, and 5 mg of BioPerine Black Pepper (

“People should take liver health seriously, as it supports metabolism, immunity, digestion, detoxification, and vitamin storage in the body,” said Muhammed Majeed, PhD, chairman and founder of Sabinsa, in a press release. “There is a clear market need for a scientifically rational herbal combination with all the right elements to support healthy liver function."

Curcumin C3 Complex, obtained from the dried rhizomes of turmeric, has been traditionally used to support joint, gut, and liver health. Livinol, traditionally its juice, is used as a natural remedy for stomach and liver ailments. BioPerine is a widely used nutrient bioavailability enhancer. 

LivLonga is appropriate for use as a dietary supplement in a variety of forms: tablets, capsules, and powder premixes.

Sabinsa launched a new formula to support healthy liver function called LivLonga.

Sabinsa launches liver support supplement, LivLonga

Stratum Nutrition (Carthage, MO) and KD Pharma (Bexbach, Saarland, Germany) created a partnership to develop a joint-health formula, MOVE3, combining Stratum's NEM brand eggshell membrane and KD Pharma's marine omega oils KD-Pür. Moreover, a recent study evaluated the ingredient’s effect on joint pain and stiffness after exercise.

The randomized, double-blind, placebo-controlled study, published in the

International Journal of Physical Medicine and Rehabilitation

, evaluated whether MOVE3 versus a placebo would reduce cartilage turnover and alleviate joint pain and/or stiffness immediately following exercise and 12 hours post exercise. A total of 85 healthy men and women (40-70 years) were randomly assigned to receive either 500 mg/d of eggshell membrane with 1,500 mg fish oil concentrate (n=43) or 2,000 mg/d of a placebo (n=42). 

MOVE3 produced statistically significant reductions in levels of urinary excretion of C-terminal cross-linked telopeptide of type-II collagen (uCTX-II), a marker of cartilage degradation, versus the placebo after one and two weeks of exercise. Compared with the placebo, MOVE3 also significantly relieved joint pain immediately after exercise at one week, pain 12 hours after exercise at one week, and stiffness 12 hours after exercise at one week. 

"The body of science supporting exercise and recovery benefits for both omega-3 and NEM continues to grow, but this study is unique because it demonstrates benefits in healthy people consuming the MOVE3 formulation after they have exercised," said Adam Ismail, chief strategy officer of KD Pharma Group, in a press release. "For sports nutrition products, it is important that consumers be able to feel the benefit, and the fact that we saw a significant improvement compared to placebo means the subjects not only felt the impact of MOVE3 but observed the effects in a rapid timeframe."

Kevin Ruff, PhD, MBA, senior director of scientific & regulatory affairs for Stratum Nutrition, added: "Conducting this clinical trial in exercising healthy adults will allow brands to make label claims relating to joint pain and stiffness and even cartilage protection. This is an additional benefit that MOVE3 provides beyond any other combination product on the market."

Ruff KJ, et al. “Eggshell membrane+fish oil combination (Move3) reduces exercise-induced joint pain, stiffness and cartilage turnover in healthy adults: Results from a randomized, double-blind, placebo-controlled study” 

Stratum Nutrition and KD Pharma created a partnership to develop a joint-health formula, MOVE3, combining Stratum's NEM brand eggshell membrane and KD Pharma's marine omega oils KD-Pür.

Eggshell membrane, fish oil supplement, MOVE3, reduces joint pain, stiffness after exercise, says recent study 

Search Sephora’s online catalogue for “CBD” and you’ll be directed to a selection of no fewer than 32 skincare products, 14 bath and body items, four fragrances, and two haircare SKUs.

That’s quite a selection, and the international beauty emporium wouldn’t have invested the effort or money to curate it were it not witnessing current—and anticipating future—demand for such products. And indeed, a 2019 Grand View Research 

 predicts that the global CBD skincare market will hit $1.7 billion by 2025, representing a CAGR of 32.9%.

But while topical CBD skincare and beauty products may be popular, are they even legal, as far as FDA is concerned? And regardless, do beauty brands know what it takes to navigate this changing cosmetic-formulation landscape?

First: Does FDA permit the use in skincare products and cosmetics of hemp-derived cannabidiol, or CBD, the wildly popular non-psychoactive cannabinoid that’s revolutionizing the health and personal-care spaces?

Before answering, we may first want to back up and ask: What does FDA even consider a “cosmetic” in the first place?

The answer lies in Section 201(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defines 

 as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

And that means that dermal moisturizers, nail polishes, lipsticks, eye creams, foundations, perfumes, hair colors, serums—even deodorants—all qualify, as do any substances that wind up as components of them.

And increasingly, CBD is just such a substance. “There are lots of companies out there wanting to sell topical product with CBD and hemp,” says Justin J. Prochnow, shareholder, Greenberg Traurig LLP (Denver).

And per FDA’s stance, “There’s no prohibition on using CBD or hemp in cosmetics,” he says. “While FDA has indicated that ingestible products like food, beverages, and supplements may not contain CBD or hemp with CBD, it hasn’t taken the same position for topical products.”

The reason: The exclusionary clause of the FD&C Act that the agency relies on for determining CBD’s impermissibility as an ingredient in ingestible products does not apply to topicals like cosmetics.

But that doesn’t give skincare and cosmetic brands free reign to make and market CBD products however they wish. While FDA enforces no prohibition on using CBD or hemp in cosmetics, any products thus formulated must still be safe and bear only those claims that FDA deems permissible.

“The problem for many companies is that the range of permissible claims for cosmetic and personal-care products is narrow,” Prochnow notes. Brands may market and sell only nondrug products intended to cleanse, beautify, promote attractiveness, or otherwise alter the skin’s appearance, he says—and none of those benefits appear to be attributable to CBD or hemp.

The upshot: “Companies really can’t make any claims regarding hemp or CBD in cosmetic products other than to claim the amount that’s in there,” Prochnow says. “Any claims related to pain, inflammation, anxiety, stress, or sleep—the common benefit claims made for CBD and hemp—are outside the scope of permissible claims and could cause the products to be regulated as drugs.”

Alas, he sees companies not only pushing the boundaries of permissible claims but “blowing right by” them, as well.

In the personal-care sector and wherever else CBD appears, “There are lots of products marketing and touting CBD and hemp for the treatment of pain, anxiety, stress, and sleeplessness,” Prochnow concedes.

“But FDA has taken little action except in cases where companies are making express claims,” he continues. “Basically, it’s been an issue of claims going beyond the cleansing, promoting attractiveness, and beautifying bounds of cosmetics.”

Looking forward, he doesn’t foresee the agency’s low-key stance tightening. “Again, short of safety issues or express disease claims, there’s minimal risk of action right now,” he wagers.

Chalk it up to FDA’s limited resources and seemingly unlimited responsibilities. And frankly, Prochnow observes, “Not a lot of those resources get directed toward cosmetics. There are no GMPs required for cosmetics—although some are in the works—and unless FDA finds safety issues or express disease claims, like curing skin cancer, agency action is typically somewhat limited.”

So, the winning formula for CBD-curious skincare brands is to keep claims in check: note how many milligrams are in the container and leave it at that, Prochnow says. And with individual states drafting CBD labeling requirements of their own, he adds, “Right now, violating those is the bigger risk than any FDA action.”

As is violating the labeling requirements of Sephora—for in February, the retailer 

 that it was enforcing first-in-the-industry transparency and quality standards on the CBD products it sells.

Those products must meet the Clean at Sephora rule, which requires, among other things, that CBD products prove they contain domestically grown, full- or broad-spectrum CBD and undergo third-party testing. Sephora also requires a certificate of analysis for its CBD products.

They likely won’t be the first beauty retailer to take such action. Maybe someday FDA will follow suit.

Grand View Research newswire. “CBD Skin Care Market Size Worth $1.7 Billion by 2025 | CAGR: 32.9%: Grand View Research, Inc.” Published on August 29, 2019. Accessed at: 

https://www.prnewswire.com/news-releases/cbd-skin-care-market-size-worth-1-7-billion-by-2025--cagr-32-9-grand-view-research-inc-300908941.html#:~:text=CBD%20based%20skin%20care%20oils,to%20its%20anti%2Dinflammatory%20properties

Loreto M. “Sephora Creates CBD standards for products.” Chicago Tribune. Published on February 28, 2020. Accessed at: 

https://www.chicagotribune.com/marijuana/sns-tft-sephora-cbd-standards-20200228-txx3nvrbgzc7bidpbegvxradom-story.html

Featured Content

Is CBD legal in cosmetics?

Australia, New Zealand publish digestive claims for GanedenBC30

AHPA supports USDA’s proposal to allow pullulan in products labeled organic

Poverty associated with inadequate intakes of calcium and vitamin D, says recent study

Ratite oil from ostriches and emus used in cosmetics and drugs

Stratum Nutrition to distribute NatAxtin branded astaxanthin in North America

Pharmavite’s new Caring by Nature initiative supports nurse practitioners’ health as they deal with COVID-19 work stress

Gold Coast introduces new flavors for hard seltzer products

Sabinsa launches liver support supplement, LivLonga

Eggshell membrane, fish oil supplement, MOVE3, reduces joint pain, stiffness after exercise, says recent study

Is CBD legal in cosmetics?